Republicans draw up follow-on biologics bill
WASHINGTON The Democrats’ healthcare-reform bill may have passed in the House Saturday night, but the Republicans drafted a pretty significant piece of healthcare legislation of their own, as well.
Like H.R. 3962, the Affordable Health Care for America Act, H.R. 4083, the Common Sense Healthcare Reform and Affordability Act provides a regulatory pathway that would allow the Food and Drug Administration to approve follow-on biologics. Like the Democrats’ version, it would grant manufacturers of innovator biologics a 12-year period of data exclusivity before the FDA could use its clinical trial data to approve a follow-on version of a drug.
Unlike the Democrats’ bill, however, the Republican bill does not provide a way for follow-on biologics, also called biosimilars, to be substituted for innovator biologics under Medicare and Medicaid billing systems, according to published reports.
FDA approves rare skin cancer treatment
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating a skin cancer that affects fewer than 20,000 people in the United States.
Gloucester Pharmaceuticals announced the FDA’s approval of Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma, a type of non-Hodgkin’s lymphoma also known as CTCL, in patients who have received at least one prior systemic therapy. The cancer affects between 16,000 and 20,000 people in the United States and is most common among men ages 50 years and older, according to the Cutaneous Lymphoma Foundation.
“CTCL is a devastating cancer in which many patients suffer from disfiguring tumors, horribly itchy and infected skin and, in advanced stages, lesions in other organs,” Stanford Cancer Center professor and Istodax clinical trial investigator Youn Kim stated. “Current systemic therapies have proved inadequate, and patients with CTCL desperately need treatment options that can offer sustained relief from their disease so they can live fuller lives.”
Price Chopper opens new Mass.-based store
SCHENECTADY, N.Y. Northeastern supermarket chain Price Chopper has opened a new store in Shrewsbury, Mass., the company said.
The 64,000-sq.-ft. store incorporates numerous environmentally friendly features and was designed to win silver-level certification in the U.S. Green Building Council’s Leadership in Energy and Environmental Design program. Features include skylights, freezers and cases lit with LED lightbulbs and a composting system for unused, produce, meat, seafood and deli products.
“We are so pleased to offer a brand new, state-of-the-art supermarket here in Shrewsbury that contains many of our signature products and services,” Price Chopper CEO and chairman Neil Golub said. “We look forward to providing Price Chopper quality, value and customer service to all those who enter our doors and relish the opportunity to continue supporting local projects and events that nourish the community around us.”
The store also includes a full-service pharmacy offering the chain’s 30-day and 90-day generic discount programs and the Diabetes AdvantEdge disease management program.